In re: Ethicon, Inc., A Johnson & Johnson Company


Docket No. 2015-1696 (USPTO Appeal Nos. 95/000,542 and 95/000,552)

NEWMAN(D), LOURIE, DYK
January 3, 2017

Brief Summary: Board finding of obviousness of claims directed to vascular stent affirmed.

Summary: Ethicon appealed PTAB decision in a merged inter partes reexamination regarding US 7,591,844 related to “intraluminal medical devices for the local delivery of drugs, e.g., drug-eluting stents, and methods for maintaining drugs on those devices” for use in angioplasty. The reexaminations were filed separately by Abbott and Boston Scientific (BS) after Ethicon sued each; the PTO then merged the proceedings. Ethicon cancelled claims 18 and 24, and the examiner rejected claims 1-17 and 19-23 as obvious over four patents (Tuch, Tu, Lo and Le Morel). The examiner was not persuaded by Ethicon’s objective indicia of nonobviousness (alleged copying by Abbott and BS and commercial success). The Board agreed with the examiner (e.g., alleged objective indicia of nonobviousness not shown to be “due to the claimed 85:15 VDF:HFP coating rather than to an unclaimed feature such as the drug or stent design” and “the reason to combine [the references] could be provided by the ‘normal desire of scientists or artisans to improve upon what is already generally known” (KSR, US 2007 and In re Peterson, FC 2003)). The FC panel noted its “review of a Board decision is limited” (legal determinations de novo and underlying factual determinations for substantial evidence). It also noted Graham’s (US 1966) caution “against slipping into use of hindsight”, KSR’s instruction that a combination of known elements “must do more than yield a predictable result” (see also § 103), and that analogous art is “from the same field of endeavor, regardless of the problem” or must at least be “reasonably pertinent to the particular problem”. The FC panel agreed with the Board’s analysis of the references (e.g., Tuch “lists VDF as an example of a suitable biostable polymer” and does not teach away (no clear discouragement (Tyco, FC 2014; In re Applied Materials, FC 2012); Tu “teaches that its invention” may be used in “heart valve leaflets”; Lo teaches “‘the properties of VDF-HFP’ at different ratios” (“The normal desire of artisans to improve upon what is already generally known can provide the motivation to optimize variables such as the percentage of a known polymer for use in a known device…the age of Lo [1965] does not undermine the Board’s reliance on it” (In re Wright, CCPA 1977))). It also agreed with the Board the Ethicon’s objective indicia were unpersuasive (“Ethicon relied solely on its expert’s conclusory testimony to support its copying allegation”, its “expert never opined that the results pointed to would have been unexpected”, and none were shown to be “due to the 85:15 VDF:HFP coating”.) The Board decision was therefore affirmed. Judge Newman’s dissent argued Tuch’s disclosure encompassed “thousands of polymers and copolymers” and “the specific ’844 Patent’s copolymer is not mentioned” (LeoPharma, FC 2013; Bayer, FC 2009 (“[A]n invention would not have been obvious to try when the inventor would have had to try all possibilities in a field unreduced by direction of the prior art.”); “consultation” of Tu improper as support since “[t]he Tu devices are different products requiring different properties for different purposes”; “None of the uses [of Lo] has any relation to a vascular stent or any biological application.”; “The only guide to this reconstruction is the ‘844 Patent itself.” Interconnect Planning, FC 1985); Board did not properly consider comparative data in the ‘844 patent.)

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